The etiology of hepatocarcinoma have not yet been clearly established. However, hepatocarcinoma is statistically characterized by the fact that the incidence rate is higher in men, rather than in women, who are in their forties to sixties, and it may be accompanied by hepatic cirrhosis in approximately 80% and by hepatitis C in 10%. Such characteristics are consistent with the fact that the areas in which hepatocarcinoma is predominant, such as Far east and East South Asia including Korea, Southern Europe, Africa, etc. also has a high frequency of hepatitis B virus carrier. In these areas, it may be found that hepatocarcinoma attacks in the group of one family. Further, chronic hepatic disorders including hepatic cirrhosis, chronic hepatitis, etc. have a relatively high tendency to develop hepatocarcinoma, regardless of hepatitis B and C. In addition, it has been known that the frequency to develop hepatocarcinoma from chronic hepatitis and hepatic cirrhosis may be increased 6-8 times by alcohol intake or smoking.
In many cases, hepatocarcinoma shows its unique symptoms only after it is considerably aggravated. Hepatocarcinoma shows various symptoms which include, generalized ones, such as systemic malais, anorexia, etc., hypertrophy of liver at right epigastrium and formation of mass in liver, and further a general deteriorated symptoms of hepatic cirrhosis such as ascites, jaundice, spleen hypertrophy, etc.
Up to date, the excision of the cancerated poition of liver has been considered as the most effective method for treatment of hepatocarcinoma. However, the use of such excision surgery is limited depending on the condition of hepatocarcinoma. For instance, the excision surgery cannot be applied to a person who suffers from serious hepatic cirrhosis as a secondary condition, even though his hepatocarcinoma is small and is found by early diagnosis. In addition, when hepatocarcinoma is under 3 cm, the means wherein alcohol is directly injected into cancerated portion under ultrasonographic observation to completely destruct the cancer may be utilized. Although this method has a superior effect and shows the course similar to that after surgical excision, it has substantially no effect on cancerous tumors which are greater than 3 cm.
In the case where the surgical operation may bring about fatal risk to a person suffering from hepatocarcinoma because he also suffers from considerably aggravated hepatic cirrhosis, the use of anti-cancer agents is suggested. For such a case, the administration of anti-cancer agents through oral route or common injection does not provide substantial effect but the therapeutic method either wherein the anti-cancer agent is directly injected into the cancerated liver tissue through a hepatic artery or wherein the anti-cancer agent is administered and then the blood vessel connected to the cancerated portion is occluded is mainly utilized.
Since many hepatocarcinoma tumors may lead to death, the prophylaxis of hepatocarcinoma must be prior to the therapeutic treatment of hepatocarcinoma which is already invaded. In present, the only method for prophylaxis of hepatocarcinoma is inoculation of a vaccine preparation.
Under such a situation, the present inventors have extensively studied to develop the drug which can effectively treat hepatocarcinomna and also prevent the development of hepatocarcinoma by inhibiting the progress of hepatic cirrhosis to hepatocarcinoma, particularly, using numerous compositions produced by combining various natural drugs which have been disclosed as having relatively little toxicity and side effects. As a result, we have identified that the purpose as mentioned above can be effectively attained by the combined administration of an injectable composition and an oral composition, each of which has a unique constitution as defined below, and thus completed the present invention.